FDA.report

Gemini SL Total Knee System

Primary DI
04026575195305
Brand
Gemini SL Total Knee System
Company
WALDEMAR LINK GmbH & Co. KG
Model
318-001/00
Published
2023-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K182872000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K182872000LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG2019-04-03JWH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575195305PrimaryGS10

GMDN Terms

TermDefinition
Implantable orthopaedic/craniofacial device connection screwA small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically made of metal and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other end.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315675488
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04026575081042MP Reconstruction System Instruments134-041/002026-02-02
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04026575129904MP Reconstruction System Instruments134-071/002026-02-02
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04026575131426MP Reconstruction System Instruments134-091/002026-02-02
04026575181926MP Monoblock Hip Stem Instruments136-021/002026-02-02
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04026575182022MP Monoblock Hip Stem Instruments136-011/002026-02-02

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Primary DIBrandCompanyProduct codePublished
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